Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP

McGill University

Status and phase: Unknown; Phase 3

Conditions: Low Back Pain, Mechanical

Treatments: Other: Medial branch block in one side; Other: paravertebral deep intramuscular (PDI) injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02521519

14-190

Details and patient eligibility

About

This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep intramuscular (PDI) injection for pain relief in chronic low back pain. Based on randomization in first intervention session, one side receives MBB and the other side takes PDI and in second session the pattern reverses.

Full description

Pain relief following medial branch block (MBB) might be due to facet joints desensitization and/or myofascial trigger points' desensitization. Patients will be randomized to two groups. The first group receives MBB in one side and paravertebral deep intramuscular (PDI) injection in the other side of the back. Next week the pattern of injection will be reversed so the side which had received MBB will take PDI injection and PDI side will take MBB. Second group takes the intervention in reverse order.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CLBP of non-malignant origin fulfilling the following criteria:

  • Pain lasting for at least three months
  • Pain in both the left and right sides of the back
  • Pain below the L2 vertebral body

• Lumbar spine CT scan or MRI done in the last 2 years

• Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days

• Cognitive and physical ability to provide informed consent in English or French

Exclusion criteria

• Neurologic signs or symptoms suggesting nerve root involvement

• Strictly unilateral Low Back Pain (LBP)

• CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease

  • Vascular malformations
  • Tumor
  • Infection
  • Fractures
  • DISH (Diffuse idiopathic skeletal hyperostosis)

• Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months

• Prior spine surgery

• Local or systemic infection

• Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin

• Known allergy to amid local anesthetics

• Active insurance claim (CSST, SAAQ)

• Uncontrolled psychiatric condition

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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84 participants in 2 patient groups

One side of the patient's back

Other group

Description:

medial branch block (MBB): Using sterile conditions, 25 gauge needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.

Treatment:

Other: Medial branch block in one side

Other side of the patient's back

Other group

Description:

These injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.

Treatment:

Other: paravertebral deep intramuscular (PDI) injection